Status:
TERMINATED
Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as mitomycin C and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givi...
Detailed Description
OBJECTIVES: * To assess the therapeutic activity of a mitomycin C and ifosfamide combination, in terms of progression-free survival rate at 6 months, in patients with metastatic stage IV adenocarcino...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Stage IV disease
- Metastatic disease
- Prior treatment with gemcitabine-based chemotherapy, also in the adjuvant setting, with progression-free survival at ≤ 12 months
- Measurable disease according RECIST criteria
- No symptomatic brain metastases
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100% (80-100% in patients \> 70 years of age)
- Adequate bone marrow, liver, and kidney function
- Not pregnant or nursing
- No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms with no evidence of disease ≥ 5 years
- No severe comorbidities that could compromise safety, including any of the following:
- Cardiac failure
- Cardiac arrhythmia
- Prior myocardial infarction within the past 4 months
- History of psychiatric disabilities
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior mitomycin C and ifosfamide
- No concurrent treatment with experimental drugs
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00967291
Start Date
March 1 2006
End Date
June 1 2008
Last Update
February 1 2012
Active Locations (1)
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1
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132